Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Swedish Medical Center

ClinicalTrials.gov Identifier:

NCT01260935

First received: November 30, 2010

Last updated: January 16, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2010

Last Updated Date

January 16, 2012

Start Date ^ICMJE

November 2002

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Comparison of these two surgical procedures will be based on pre- and post-surgery quality of life questionnaires, manometry (test that measures muscle pressures in the lower esophagus), pH testing, operative time, early complication rates, and length of hospital stay.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01260935 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Official Title ^ICMJE

A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Brief Summary

The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.

Detailed Description

The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate "expertise" bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Gastroesophageal Reflux
Esophageal Reflux
Gastroesophageal Reflux Disease
GERD

Intervention ^ICMJE

Procedure: Laparoscopic Hill Repair
With the Hill repair, stitches are placed right where the esophagus and stomach meet and attached to muscle tissue that is fixed to the spine.
Procedure: Laparoscopic Nissen Repair
With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.

Study Arm (s)

Active Comparator: Arm A
Laparoscopic Hill

Intervention: Procedure: Laparoscopic Hill Repair
Active Comparator: Arm B
Laparoscopic Nissen

Intervention: Procedure: Laparoscopic Nissen Repair

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

121

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control
> 18 years of age and < 75 years of age

Exclusion Criteria:

hiatal hernias measuring > 7 cm
esophageal body amplitude < 30 or in two or more segments
< 40% propagated peristaltic waves
GE junction > 5 cm above the esophageal hiatus
dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy
body mass index > 40

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01260935

Other Study ID Numbers ^ICMJE

IR 3722

Has Data Monitoring Committee

Responsible Party

Swedish Medical Center

Study Sponsor ^ICMJE

Swedish Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ralph Aye, MD

Swedish Medical Center Cancer Institute

Information Provided By

Swedish Medical Center

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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